An interventional study of Second Life and Group Phone Conference Call in Weight Loss, sponsored by University of Kansas Medical Center. Completed at 1 site in United States. Open to participants aged 21 Years to 65 Years. Per ClinicalTrials.gov, last updated 2020-03-25.
Sponsored by University of Kansas Medical Center · Not applicable, Interventional, and Treatment
The purpose of this study is to determine if use of a virtual reality platform, Second Life, is more effective than traditional face-to-face methods for maintaining weight loss in overweight and obese individuals.
This study has two main parts. During the first 6 months (-6 to 0 months)potential subjects will be on a diet developed by researchers at the University of Kansas Medical Center (KUMC). Subsequent to 6 months, participants who lost 5% weight will begin the weight maintenance phase of the study (0-12 months). Thus the total duration of the study is 18 months.
Approximately 68% of U.S. adults are classified as overweight or obese (BMI >25). Behaviorally based weight loss programs, typically delivered by face-to-face clinics, produce clinically significant reductions in body weight over 3-6 months. However, approximately 50% of those who lose weight regain more than 45-75% of the weight lost within 12-30 months. Face-to-face clinics present many barriers and burdens to individuals including scheduling and logistical and financial burdens.
Virtual Reality (VR) environments allow participants to create virtual representations of themselves called "avatars". An existing VR called "Second Life" will be used for participants randomized to VR. Participants avatars attend group meetings and use headsets for voice communication to interact with each other.
Those not randomized to VR will participate in traditional face-to-face group weight loss intervention. The study will examine many different factors to determine if those participants in the Second Life group experience improved weight maintenance.
1,223 studies on the registry are indexed under Body Weight; 131 are open to participants now.
This study's planned enrollment of 202 is above the median of 64 across 947 interventional studies indexed under Body Weight.
Browse Body Weight studies →University of Kansas Medical Center is the lead sponsor of 483 studies on the registry; 113 are open to participants now.
Of its 38 completed or terminated interventional studies of FDA-regulated products, 24 (63%) have results posted.
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Exclusion Criteria:
Group phone clinic will be conducted weekly during the first 9 months and twice/month during the final 9 months (3 to 12 months).
Behavioral: Group Phone Conference Call
2L group meeting will be conducted weekly during the first 9 months and twice/month during the final 9 months
Other: Second Life
Second Life is an online virtual reality environment.
Difference in Weight Change
Weight change measured during Month 0 (after 6 mo weight loss) to Month 12.
Time frame: Change from month 0 (after 6 mo weight loss) to Month 12
Total Attendance at Meetings
Number of times each individual attended group meeting during the course of the weight maintenance phase.
Time frame: Month 0 to12 Months
Assessment of Self-Efficacy for Weight Loss
Weight loss self-efficacy will be assessed using the Weight Efficacy Lifestyle Questionnaire. This scale assess overeating in tempting situations. Participants rate their level of confidence on a 10-point Likert-scale with higher values indicating greater confidence to resist overeating.
Time frame: Change from Month 0 to 12 Months
Assessment of Self-Efficacy for Physical Activity (PA)
Physical activity self-efficacy will be assessed using the 5-item exercise self-efficacy scale. Participants rate their confidence level (1 = not confident at all to 7 = very confident) to engage in PA in a number of different situations including making time for exercise, resisting lapse, etc.
Time frame: Change from Month 0 to 12 Months
Assessment of Self-Efficacy for Problem Solving Skills
Problem-solving abilities will be assessed using the Social Problem Solving Inventory-Revised, short form (SPSI-R:S). The SPSI-R:S is a 25-item instrument with five component scales to assess problem-solving styles and solution generation.
Time frame: Change from Month 0 to 12 Months
This study is completed, as verified in Mar 2020. You cannot join it, but the record below documents what was studied.
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University of Kansas Medical Center